ALSPhase 2Pimozide2NCT03272503
A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing Pimozide 2mg/day (current) or 4 mg/day (study initiation) in people with ALS and Amyotrophic Lateral Sclerosis, run by University of Calgary at 9 sites in Canada.
Trial summary
This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis. 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS, Amyotrophic Lateral Sclerosis
- What is being tested?
- Pimozide 2mg/day (current) or 4 mg/day (study initiation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 9 sitesCanada
- Study dates
- 27 Oct 2017to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients classified as having clinically definite, clinically probable, clinically probable (laboratory-supported) or clinically possible ALS according to the El-Escorial diagnostic criteria for ALS (see Appendix 2).
- Able to comprehend and willing to sign Informed Consent Form (ICF).
- Age 18 years of age or greater.
- ALS Symptom onset of muscle weakness or speech impairment no more than 48 months prior to screen visit. Fasiculations should not be considered.
- Slow Vital Capacity (SVC) greater than or equal to 50% predicted for sex, age and height at screen.
- Has the ability to swallow tablets/capsules whole at study entry.
Show all 9Show fewer
- Subject with clinical laboratory findings within the normal range or, if outside the normal range, determined by the Investigator at the Screening visit to be not clinically significant.
- If the subject is taking Riluzole the dose must be stable for 30 days prior to the randomization visit. Riluzole cannot be initiated during the study.
- If the subject is receiving Edaravone therapy, the dose must be stable for at least 1 cycle of infusion treatments before the randomization visit.
Who cannot join
- History of laryngeal spasm, dystonia, or akathisia.
- Diagnosis of ongoing symptomatic Restless Leg Syndrome or undergoing current treatment for Restless Leg Syndrome. If subject has symptoms that resemble or have the potential to be Restless Leg Syndrome, then further investigation should be undertaken to confirm or rule out diagnosis of Restless Leg Syndrome.
- Any history of moderate or severe traumatic brain injury as defined by a Glasgow Coma Scale Score of less than 13/15 at any time point following a head injury without sedation or other reason for a decreased level of consciousness.
- History of neuroleptic malignant syndrome.
- History of hypersensitivity or serious adverse reaction(s) to a neuroleptic medication.
- History of hyponatremia < 130 mmol/L
Show all 31Show fewer
- Subject with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper limit of normal at the Screening visit.
- Current heparin or warfarin use.
- History of hepatic and/or renal impairment that may affect pimozide metabolism
- History of current pregnancy, or breastfeeding women, or women planning to become pregnant. Female subjects of childbearing potential (sexually mature female who has not undergone a hysterectomy or who has not been post-menopausal for 12 consecutive months), must practise effective contraception during the study and be willing and able to continue contraception until the Follow-up phone visit after discontinuing study medication. Abstinence can be considered an acceptable method of contraception at the discretion of the investigator.
- Current antipsychotic use
- Presence of central nervous system depression, comatose states, liver disorders, renal insufficiency, and blood dyscrasias
- Presence of Parkinson's syndrome
- Presence of major depressive disorders as determined by site Investigator.
- History of clinically significant ECG abnormalities at screen visit, including QTc>500ms.
- History of congenital long QT syndrome or with a family history of this syndrome and in patients with a history of cardiac arrhythmias or Torsade de Pointes.
- Presence of acquired long QT interval, and/or concomitant use of drugs known to prolong the QT interval (TCAs, opioids such as methodone, quinolone antibiotics (ciprofloxacin), antimalarials (quinine), Detrol, azole antifungals, Class 1A, III and 1C antiarrhythmics, and macrolide antibiotics.
- Presence of clinically significant bradycardia (heart rate < 50 beats per minute)
- Presence of hypokalemia or hypomagnesemia.
- The concomitant use of CYP 3A4-inhibiting drugs such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and nefazodone.
- The concomitant use of CYP 2D6-inhibiting drugs such as quinidine is also contraindicated.
- Concomitant use of serotonin reuptake inhibitors, such as, sertraline, paroxetine, citalopram and escitalopram.*
- Has taken any compound under current or known future study as a potential therapy (including Withania) for ALS less than 30 days prior to dosing OR history of exposure to stem cell therapy for treatment of ALS at any time.
- Current Neurological impairment due to a condition other than ALS:
- Subject in whom causes of neuromuscular weakness other than ALS have not been excluded.
- Subject with a diagnosis of other neurodegenerative diseases (e.g., Parkinson's disease, Frontotemporal dementia, Alzheimer's disease, etc.)
- Use of non-invasive ventilation (BiPAP or CPAP) prior to Baseline visit at any time.
- Cognitive impairment as determined by the Site Investigator, subject must not have an impaired ability to provide informed consent and must be able to understand study processes and comply with study procedures.
- Extrapyramidal Symptom Rating Scale (ESRS) Parkinsonism score of 2 on 2 items or a score > 3 on 1 item; OR Dystonia score of >3 on at least 1 item or a score of 2 on 2 items; OR Tardive Dyskinesia score of >3 on at least 1 item or a score of 2 on 2 items. Do not consider scores greater than 3 for Tremor in any region if due to Benign Essential, Exaggerated, or Physiological Tremor.
- The concomitant use of SSRIs and tricyclic antidepressants (e.g. amitriptyline, amoxaprine, desipramine, doxepin, imipramine, nortriptyline, protripyline, trimipramine) - and Tolterodine (Detrol) CYP2D6 inhibitor.
- Prohibited medications such as tricyclic antidepressants, antimalarials, and serotonin reuptake inhibitors,(ie sertraline, paroxetine, citalopram, fluoxetine, vilazodone and escitalopram) may be weaned to full discontinuation at the screening visit after consent has been signed (no study procedures including adjustments to medication may occur until informed consent has been provided).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites, 9 recruiting
- Recruiting
Dr. Lawrence Korngut -South Health Campus
Calgary, Alberta, T3M 1M4
Janet Petrillo, MSc, 403-210-7006, japetril@ucalgary.ca
- Recruiting
Dr. Wendy Johnston - University of Alberta
Edmonton, Alberta, T6G2G3
Kelsey Tymkow, 780-492-7690, tymkow@ualberta.ca
- Recruiting
Dr. Colleen O'Connell - Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7
Susan McCully, MN, 506-447-4095, susan.mccully@horizonnb.ca
- Recruiting
Dr. Sandrine Larue - Reserche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2
Kim Desilets, B.Sc., 450-672-1931 ext. 247, larue@neurorivesud.ca
- Recruiting
Dr. John Turnbull McMaster University/Hamilton Health Services
Hamilton, Ontario, L8N 3Z5
Daniela Trapsa, 905-521-2100 ext. 76365, trapsd@mcmaster.ca
- Recruiting
Dr. Christen Shoesmith - London Health Sciences Centre
London, Ontario, N6A5A5
Christine Piechowicz, BA, 519-685-8500 ext. 34858, christine.piechowicz@lhsc.on.ca
- Recruiting
Dr. Genevieve Matte
Montreal, Quebec, H2L4M1
Micheline Gravel, 514-890-8000 ext. 13616, micheline.gravel.chum@ssss.gouv.qc.ca
Stefanie Houle, 514-890-8000 ext. 27208, stefanie.houle.chum@ssss.gouv.qc.ca
- Recruiting
Dr. Ariel Breiner -Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y4E9
Sergio Guber, MSc, 613-798-5555 ext. 19627, sguber@ohri.ca
- Recruiting
Dr. Lorne Zinman Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Liane Phung, BSc, 416-480-6100 ext. 87561, liane.phung@sri.utoronto.ca
Shirley Pham, BA, 416-480-6860, shirley.pham@sunnybrook.ca
About this study
Official title: A Phase II Randomized, Placebo-Controlled, Double Blinded, Multi-Centre Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis
This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis.
100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.
Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease is a neuromuscular disease that results in rapid decline in normal muscle function and tone leading to difficulties with mobility, eating, drinking, breathing, sleeping, and communicating. The disease is progressive and no cure currently exists. Most people diagnosed with ALS succumb within 3 to 5 years. Rilutek® (riluzole) has been approved as a treatment to slow progression of ALS, but is minimally effective with mean increase in survival of only a few months. Radicava® or Radicut® (edaravone) has recently been approved in Canada, USA, Japan and South Korea.
Muscular dysfunction present in people with ALS is caused by nerve breakdown and a dysfunction in the communication between the muscles and the nerves. The area where these communications occur is called the neuromuscular junction. Some recent studies have focused on using different medications to enhance communication at the neuromuscular junction with the goal of improving muscle function as a result. This approach is unproven but may help to slow the progression of the disease.
Pimozide is a medication that has been demonstrated to enhance communication at the neuromuscular junction in fish and mice. This study will look at whether Pimozide may help to slow the progression of ALS.
There are two parts to this study.
Treatment Phase: In the first part of this study, 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.
Each Pimozide tablet contains 2 mg of Pimozide. The matching placebo tablets for this study will look exactly like the Pimozide tablets. Placebos are used in clinical trials to find out if the results observed in the study are due the drug being tested, or for other reasons.
Neither the subject nor their doctor will know which group a patient belongs to. However, if an emergency should arise, information about a treatment group will be shared with their doctor to ensure appropriate medical care. Participants will take their treatment once a day, every day for about 22 weeks. The total time in the study from the screen visit up until the last phone call communication is about 26 weeks.
Observational Phase: The second part of this study is optional. It is each subject's decision whether to participate only in the first part of this study, or in both parts of the study, or not at all. In the second part of this study, the Canadian Neuromuscular Disease Registry (CNDR) will collect data on overall ALS progression using the Revised ALS Functional Rating Scale (ALSFRS-R) and breathing using Vital Capacity data collected during breathing tests. This information will be collected from a subject medical record following each routine clinical appointment. Data will be collected at each routine clinic visit for up to 5 years from the end of the first part of the study. There will be no extra visits for this part of the study beyond routine ALS clinic visits.
The information collected during this part of the study will be used to compare the progression of ALS, after the clinical trial is completed, among the two treatment types (Placebo or 2 mg per day). By analyzing this information, the researchers conducting this study hope to determine if Pimozide may help to slow the progression of ALS. To participate in this part of the study consent must be provided to join the CNDR. A subject who hasn't already provided their CNDR consent, and wishes to participate in this part of the study will be given a CNDR consent form to review and sign in addition to this consent form. A subject already participating in the CNDR will just need to sign the main study consent form.
- Conditions
- ALS, Amyotrophic Lateral Sclerosis
- Being tested
- Pimozide 2mg/day (current) or 4 mg/day (study initiation), Placebo Oral Tablet
- Keywords
- Pimozide
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimozide 2mg/day (current) or 4 mg/day (study initiation)Drug
Pimozide 2mg tablets will be taken once daily.
Placebo Oral TabletDrug
Identical matching placebo lactose tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Pimozide 2 mg (current) or 4 mg/day (study initiation) | Experimental | Pimozide will be initiated at 2 mg once daily. The maximum dose will then be administered for a target period of 22 weeks. Receives: Drug: Pimozide 2mg/day (current) or 4 mg/day (study initiation) |
| Group 2 Placebo | Placebo comparator | Placebo tablets will be utilized and administered in an identical manner for subjects in Group 1 Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALS Functional Rating Scale-Revised (ALSFRS-R)
The Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) consists of a 12 item questionnaire which asks about function in certain daily activities. Takes around 5-10 mins with a study staff member.
Measured: Change from Baseline (week 2), at visit each of visit weeks 4, 8,12,16,20, week 24 Final Study visit, and week 26 follow-up phone call. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Secondary outcomes (6)
Change in Slow Vital Capacity (SVC)
The SVC is the maximum volume of air which can be exhaled after a deep breath in, during a slow/steady maneuver. A nose clip will be placed on the nose during the testing.
Measured: Change from screen, at each of visit weeks 8, week 16, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Decremental responses on repetitive nerve stimulation (DRRNS)
Repetitive Nerve Stimulation is where electrical stimulation is applied to a motor nerve repeatedly several times per second. This will involve testing each thumb.
Measured: Change from Baseline (week 2) at week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Motor Power - the MRC (Medical Research Council) Sum Score
Assessment of Muscle Strength
Measured: Change from screen, at each of week 8, week 16, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Common Terminology Criteria for Adverse Events (CTCAE) will be entered for each visit for adverse effect profile analysis
Adverse events will be assessed.
Measured: Change from Baseline (week 2), at each of weeks 4,8,12,16,20, week 24 Final Study visit, and week 26 follow-up phone call. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in ALS-Specific QOL -Revised
The Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R) questionnaire consists of 50 items regarding quality of life. Takes approximately 15 minutes to complete
Measured: Change from Baseline (week 2), at week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Cramp Frequency and Severity
Consists of 2 questions asking if subject has had cramps in the last 24 hours, how bad and how severe they were. Takes 1 or 2 minutes to complete.
Measured: Change from Baseline (week 2), at each of weeks 4,8,12,16,20, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start27 Oct 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Canada, Brain Canada
- Responsible party
- Principal investigator, DR. LAWRENCE KORNGUT, University of Calgary
- Investigators
- Lawrence Korngut, M.D., Principal investigator, University of Calgary and Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272503
- Sponsor's protocol ID
- Pimozide2_ALS-002
- Acronym
- Pimozide2
- Status last verified
- May 2020
- First submitted
- 31 Aug 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled, Double Blinded, Multi-Centre Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03272503
- Acronym / sponsor ID
- Pimozide2 / Pimozide2_ALS-002
- Conditions
- ALS, Amyotrophic Lateral Sclerosis
- Keywords
- Pimozide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- ALS Canada, Brain Canada
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis.
100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.
Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.
Detailed description
Amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease is a neuromuscular disease that results in rapid decline in normal muscle function and tone leading to difficulties with mobility, eating, drinking, breathing, sleeping, and communicating. The disease is progressive and no cure currently exists. Most people diagnosed with ALS succumb within 3 to 5 years. Rilutek® (riluzole) has been approved as a treatment to slow progression of ALS, but is minimally effective with mean increase in survival of only a few months. Radicava® or Radicut® (edaravone) has recently been approved in Canada, USA, Japan and South Korea.
Muscular dysfunction present in people with ALS is caused by nerve breakdown and a dysfunction in the communication between the muscles and the nerves. The area where these communications occur is called the neuromuscular junction. Some recent studies have focused on using different medications to enhance communication at the neuromuscular junction with the goal of improving muscle function as a result. This approach is unproven but may help to slow the progression of the disease.
Pimozide is a medication that has been demonstrated to enhance communication at the neuromuscular junction in fish and mice. This study will look at whether Pimozide may help to slow the progression of ALS.
There are two parts to this study.
Treatment Phase: In the first part of this study, 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.
Each Pimozide tablet contains 2 mg of Pimozide. The matching placebo tablets for this study will look exactly like the Pimozide tablets. Placebos are used in clinical trials to find out if the results observed in the study are due the drug being tested, or for other reasons.
Neither the subject nor their doctor will know which group a patient belongs to. However, if an emergency should arise, information about a treatment group will be shared with their doctor to ensure appropriate medical care. Participants will take their treatment once a day, every day for about 22 weeks. The total time in the study from the screen visit up until the last phone call communication is about 26 weeks.
Observational Phase: The second part of this study is optional. It is each subject's decision whether to participate only in the first part of this study, or in both parts of the study, or not at all. In the second part of this study, the Canadian Neuromuscular Disease Registry (CNDR) will collect data on overall ALS progression using the Revised ALS Functional Rating Scale (ALSFRS-R) and breathing using Vital Capacity data collected during breathing tests. This information will be collected from a subject medical record following each routine clinical appointment. Data will be collected at each routine clinic visit for up to 5 years from the end of the first part of the study. There will be no extra visits for this part of the study beyond routine ALS clinic visits.
The information collected during this part of the study will be used to compare the progression of ALS, after the clinical trial is completed, among the two treatment types (Placebo or 2 mg per day). By analyzing this information, the researchers conducting this study hope to determine if Pimozide may help to slow the progression of ALS. To participate in this part of the study consent must be provided to join the CNDR. A subject who hasn't already provided their CNDR consent, and wishes to participate in this part of the study will be given a CNDR consent form to review and sign in addition to this consent form. A subject already participating in the CNDR will just need to sign the main study consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Pimozide 2 mg (current) or 4 mg/day (study initiation) | Experimental | Drug: Pimozide 2mg/day (current) or 4 mg/day (study initiation)Pimozide will be initiated at 2 mg once daily. The maximum dose will then be administered for a target period of 22 weeks. |
| Group 2 Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablets will be utilized and administered in an identical manner for subjects in Group 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients classified as having clinically definite, clinically probable, clinically probable (laboratory-supported) or clinically possible ALS according to the El-Escorial diagnostic criteria for ALS (see Appendix 2).
- Able to comprehend and willing to sign Informed Consent Form (ICF).
- Age 18 years of age or greater.
- ALS Symptom onset of muscle weakness or speech impairment no more than 48 months prior to screen visit. Fasiculations should not be considered.
- Slow Vital Capacity (SVC) greater than or equal to 50% predicted for sex, age and height at screen.
Key exclusion criteria (31 listed)
- History of laryngeal spasm, dystonia, or akathisia.
- Diagnosis of ongoing symptomatic Restless Leg Syndrome or undergoing current treatment for Restless Leg Syndrome. If subject has symptoms that resemble or have the potential to be Restless Leg Syndrome, then further investigation should be undertaken to confirm or rule out diagnosis of Restless Leg Syndrome.
- Any history of moderate or severe traumatic brain injury as defined by a Glasgow Coma Scale Score of less than 13/15 at any time point following a head injury without sedation or other reason for a decreased level of consciousness.
- History of neuroleptic malignant syndrome.
- History of hypersensitivity or serious adverse reaction(s) to a neuroleptic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimozide 2mg/day (current) or 4 mg/day (study initiation)Pimozide 2mg tablets will be taken once daily. | Drug | Group 1 Pimozide 2 mg (current) or 4 mg/day (study initiation) |
| Placebo Oral TabletIdentical matching placebo lactose tablets | Drug | Group 2 Placebo |
Primary outcome
Change in ALS Functional Rating Scale-Revised (ALSFRS-R)
Time frame: Change from Baseline (week 2), at visit each of visit weeks 4, 8,12,16,20, week 24 Final Study visit, and week 26 follow-up phone call. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
The Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) consists of a 12 item questionnaire which asks about function in certain daily activities. Takes around 5-10 mins with a study staff member.
6 secondary outcomes
Change in Slow Vital Capacity (SVC)
Time frame: Change from screen, at each of visit weeks 8, week 16, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Decremental responses on repetitive nerve stimulation (DRRNS)
Time frame: Change from Baseline (week 2) at week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Motor Power - the MRC (Medical Research Council) Sum Score
Time frame: Change from screen, at each of week 8, week 16, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Common Terminology Criteria for Adverse Events (CTCAE) will be entered for each visit for adverse effect profile analysis
Time frame: Change from Baseline (week 2), at each of weeks 4,8,12,16,20, week 24 Final Study visit, and week 26 follow-up phone call. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in ALS-Specific QOL -Revised
Time frame: Change from Baseline (week 2), at week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Change in Cramp Frequency and Severity
Time frame: Change from Baseline (week 2), at each of weeks 4,8,12,16,20, and week 24 Final Study visit. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Korngut, M.D. principal investigator
University of Calgary and Alberta Health Services
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimozide 2mg/day (current) or 4 mg/day (study initiation) in people with ALS and Amyotrophic Lateral Sclerosis, run by University of Calgary at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pim2 Study (403-210-7006, Pimozide2@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ALS Functional Rating Scale-Revised (ALSFRS-R) (time frame: Change from Baseline (week 2), at visit each of visit weeks 4, 8,12,16,20, week 24 Final Study visit, and week 26 follow-up phone call. Will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.