SchizophreniaPhase 1/2DLP-114NCT04418466
Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
A Phase 1/2 study testing Risperidone in people with Schizophrenia, run by Delpor, Inc. at 2 sites in United States.
Trial summary
This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 10 Feb 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18-70 years of age of both sexes diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual (DSM)-V who have been stable on oral risperidone (2mg-3mg) for at least 2 weeks.
- Patient (and/or a patient's authorized legal representative) has provided written informed consent
- Patient meets the following criteria:
- Outpatient status
- PANSS Total Score ≤ 80 at screening.
- A score of ≤ 4 on the following PANSS items:
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- Conceptual disorganization ii. Suspiciousness iii. Hallucinatory behavior iv. Unusual thought content v. Hostility d. Clinical Global Impression Scale (CGI-S) ≤ 4 (moderately ill)\Lack of clinically significant suicidal ideation or behavior; Columbia Suicide Severity Rating Scale (C-SSRS) score type of 4-5 require evaluation by mental health professional to ensure patient safety in study
- Body Mass Index (BMI) within the range of 18.5 to 40.0 kg/m2 (inclusive);
- Ability to understand the nature and objectives of the trial, including risks and adverse events, and be able to read, review and sign the informed consent document prior to conduct of any study procedures;
- Willing and able to comply with the requirements of the study protocol; including willingness to visit the clinical facility for all outpatient visits and confinement periods;
- Have suitable venous access for blood sampling.
- Patient is assessed by the Investigator to be symptomatically stable with regard to pre-existing medical conditions as evidenced by medical history, non-clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current prescribed medication regimens to control pre-existing medical and psychiatric conditions (other than schizophrenia) including the use of prescribed PRN medications.
Who cannot join
- PANSS score at baseline is ≥ 20% change from screening.
- Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
- Patient has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide.
- Patient experiencing acute depressive symptoms within the past 30 days, according to the Investigator's opinion, that required treatment with an antidepressant
- Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
- Have impaired hepatic (Alanine transaminase (ALT) /aspartate aminotransferase (AST) >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)
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- Previously defined hypersensitivity to Risperidone
- History of neuroleptic malignant syndrome (NMS)
- Electroconvulsive therapy within 6 months of admission
- Requires current use of agents that are strong inhibitors and inducers of cytochrome P450;
- Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures);
- Presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the investigator;
- History of clinically significant hypersensitivity or allergic reactions;
- Known allergy or hypersensitivity to para-aminobenzoic acid (PABA);
- Known allergy or hypersensitivity to parabens, local anesthetics of the ester type, and sulfa drugs including antibiotics and thiazide diuretics;
- Known hypersensitivity to titanium, implant materials or procedure;
- Administration of an investigational drug or device within 1 month prior to first dosing;
- Positive result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or HIV antibody;
- Pregnant or lactating patients. Positive pregnancy test;
- Positive drug test for Methamphetamines, Opiates, Cocaine, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, Antidepressants and Amphetamines or positive alcohol test at screening or prior to first dose;
- Poor CYP2D6 metabolizer;
- History of skin picking or delusional parasitosis;
- Known history of abnormal scar formation or family history of keloid formation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Research
Long Beach, California, 90806
Segal Trials
Miami Lakes, Florida, 33016
About this study
Official title: Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (DLP-114)
This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114).
Read the detailed description
Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and Pharmacokinetics of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.
- Conditions
- Schizophrenia
- Being tested
- Risperidone
- Keywords
- risperidone, schizophrenia, implant
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneCombination product
Also called DLP-114
Risperidone Implant
| Study group | Role | What they receive |
|---|---|---|
| DLP-114 alpha-4 (6-months) | Experimental | Group 1: 6-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (360mg of Risperidone per implant) for 6 months Receives: Combination Product: Risperidone |
| DLP-114 alpha-7 (12-months) | Experimental | Group 2: 12-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (435mg of Risperidone per implant) for 12 months Receives: Combination Product: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Participants with Treatment-Emergent Adverse Events.
Measured: Up to 8 months and up to 15 months for groups 1 and 2 respectively.
Percentage of Implant Site Assessments With a Dermal Irritation Scale Rating Greater Than Zero
Evaluate the incidence of local site reactions. Percentage of implant site assessments with a dermal irritation scale rating greater than zero (rating scale is 0 to 4, where 0 indicates no erythema or edema, and 4 indicates erythema or slight eschar).
Measured: 6 months and 12 months for groups 1 and 2 respectively.
Number of Participants Who Experienced an AE Related to Implantation or Explantation Procedures
Number of participants who experienced an Adverse Events related to Implantation or Explantation Procedures
Measured: 6 months and 12 months for groups 1 and 2 respectively.
Secondary outcomes (7)
Oral Phase Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During 24 Hours After 3 Days of Repeated 3mg QD Oral Administrations
Oral Phase Cave: Average plasma concentration of active moiety (risperidone + 9 OH risperidone) during 24 hours after 3 days of repeated 3mg QD oral administrations
Measured: t=0, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours following oral administration.
Implant Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During the Implant Phase
Average plasma concentration of active moiety (risperidone + 9 OH risperidone) following switch from oral risperidone to subcutaneous implantation of two DLP-114 devices at specific time intervals per protocol for 6 months or 12 months (groups 1 and 2 respectively).
Measured: PK blood draw & analysis were performed per protocol time intervals; 0, 1, 2, 3, 4, 6, 8, 12, 24, 28, 32, 36, 48, and 52 hours post-placement of implants; 1x/day for 4 additional days, 1x/week during days 5-28; biweekly until day of device removal.
Average Positive and Negative Syndrome Scale (PANSS) During the Study (Oral & Implant Phases)
Average Positive and Negative Syndrome Scale (PANSS) during the study (Oral \& Implant Phases). The average PANSS score was calculated for each participant during the study. The PANSS score reported is the average of all participants who completed the study in each group. The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology)
Measured: For group 1: Screening period, day -1, day 84, day 183; and for Group 2: Screening period, day -1, day 84, day 182, day 280, day 364.
Average Clinical Global Impression-Improvement (CGI-I) Scale During the Implant Phase
Average Clinical Global Impression-Improvement (CGI-I) Scale during the Implant Phase. The average CGI-I score was calculated for each participant during the Implant Phase. The CGI-I score reported is the average of all participants who completed the study in each group. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Measured: CGI-I assessments were conducted over the course of the study per the protocol schedule of assessments. For Group 1: day 7, 14, 28, 42, 70, 112,140, 68, 183 and for Group 2: day 7, 14, 28, 56, 84, 112,140, 168,182, 210, 238, 252, 280, 308, 336, 350, 364.
Average Daily Risperidone Implant Output During the Implant Phase
Average daily Risperidone Implant output during the Implant Phase. Average daily output is calculated by using the amount of Risperidone drug substance remaining in the DLP-114 reservoir following removal. The average daily output is calculated for each participant by using the two devices that each participant received. Risperidone output reported as the average for each group.
Measured: 6-months and 12-months for groups 1 and 2 respectively. Remaining Risperidone measurements taken at the end of the Implant Phase.
Implant Device Placement Depth
Average depth of implant device placement measured by ultrasound in mm. The average depth was calculated for each participant. The implant device depth reported is the average of all participants who completed the study in each group.
Measured: Group 1 (6-month): Ultrasound on days 14 and 183. Group 2 (12-month): Ultrasound on days 14 and 364.
Number of Participants Who Experienced Implant Migration in at Least One of the Implanted Devices
Implant migration is defined as a distance of greater than 3cm between the initial incision and the proximal end of the implant device prior to removal.
Measured: Group 1 (6-month): Assessments performed day 1 and day 183. Group 2 (12-month): Assessments performed day 1 and 364.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Apr 2021
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delpor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418466
- Sponsor's protocol ID
- DLP-114-03
- Other IDs
- R44MH094036
- Acronym
- DLP-114
- Status last verified
- Dec 2024
- First submitted
- 1 Jun 2020
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (DLP-114)
- ClinicalTrials.gov ID
- NCT04418466
- Acronym / sponsor ID
- DLP-114 / DLP-114-03
- Conditions
- Schizophrenia
- Keywords
- risperidone, schizophrenia, implant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Delpor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114).
Detailed description
Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and Pharmacokinetics of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLP-114 alpha-4 (6-months) | Experimental | Combination Product: RisperidoneGroup 1: 6-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (360mg of Risperidone per implant) for 6 months |
| DLP-114 alpha-7 (12-months) | Experimental | Combination Product: RisperidoneGroup 2: 12-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (435mg of Risperidone per implant) for 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult patients 18-70 years of age of both sexes diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual (DSM)-V who have been stable on oral risperidone (2mg-3mg) for at least 2 weeks.
- Patient (and/or a patient's authorized legal representative) has provided written informed consent
- Patient meets the following criteria:
- Body Mass Index (BMI) within the range of 18.5 to 40.0 kg/m2 (inclusive);
- Ability to understand the nature and objectives of the trial, including risks and adverse events, and be able to read, review and sign the informed consent document prior to conduct of any study procedures;
Key exclusion criteria (23 listed)
- PANSS score at baseline is ≥ 20% change from screening.
- Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
- Patient has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide.
- Patient experiencing acute depressive symptoms within the past 30 days, according to the Investigator's opinion, that required treatment with an antidepressant
- Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
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 |
|---|---|---|
| RisperidoneAlso: DLP-114Risperidone Implant | Combination product | DLP-114 alpha-4 (6-months), DLP-114 alpha-7 (12-months) |
Primary outcome
Adverse Events
Time frame: Up to 8 months and up to 15 months for groups 1 and 2 respectively.
Number of Participants with Treatment-Emergent Adverse Events.
Percentage of Implant Site Assessments With a Dermal Irritation Scale Rating Greater Than Zero
Time frame: 6 months and 12 months for groups 1 and 2 respectively.
Evaluate the incidence of local site reactions. Percentage of implant site assessments with a dermal irritation scale rating greater than zero (rating scale is 0 to 4, where 0 indicates no erythema or edema, and 4 indicates erythema or slight eschar).
Number of Participants Who Experienced an AE Related to Implantation or Explantation Procedures
Time frame: 6 months and 12 months for groups 1 and 2 respectively.
Number of participants who experienced an Adverse Events related to Implantation or Explantation Procedures
7 secondary outcomes
Oral Phase Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During 24 Hours After 3 Days of Repeated 3mg QD Oral Administrations
Time frame: t=0, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours following oral administration.
Implant Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During the Implant Phase
Time frame: PK blood draw & analysis were performed per protocol time intervals; 0, 1, 2, 3, 4, 6, 8, 12, 24, 28, 32, 36, 48, and 52 hours post-placement of implants; 1x/day for 4 additional days, 1x/week during days 5-28; biweekly until day of device removal.
Average Positive and Negative Syndrome Scale (PANSS) During the Study (Oral & Implant Phases)
Time frame: For group 1: Screening period, day -1, day 84, day 183; and for Group 2: Screening period, day -1, day 84, day 182, day 280, day 364.
Average Clinical Global Impression-Improvement (CGI-I) Scale During the Implant Phase
Time frame: CGI-I assessments were conducted over the course of the study per the protocol schedule of assessments. For Group 1: day 7, 14, 28, 42, 70, 112,140, 68, 183 and for Group 2: day 7, 14, 28, 56, 84, 112,140, 168,182, 210, 238, 252, 280, 308, 336, 350, 364.
Average Daily Risperidone Implant Output During the Implant Phase
Time frame: 6-months and 12-months for groups 1 and 2 respectively. Remaining Risperidone measurements taken at the end of the Implant Phase.
Implant Device Placement Depth
Time frame: Group 1 (6-month): Ultrasound on days 14 and 183. Group 2 (12-month): Ultrasound on days 14 and 364.
Number of Participants Who Experienced Implant Migration in at Least One of the Implanted Devices
Time frame: Group 1 (6-month): Assessments performed day 1 and day 183. Group 2 (12-month): Assessments performed day 1 and 364.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Risperidone in people with Schizophrenia, run by Delpor, Inc. at 2 sites in United States.
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 12 inclusion and 23 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 8 months and up to 15 months for groups 1 and 2 respectively.). The study lists 3 primary outcomes in all. 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 27 Dec 2024.