StrokePhase 3NCT01800097
Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent
A Phase 3 study testing modafinil in people with Stroke and Post Stroke Fatigue, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Post Stroke Fatigue
- What is being tested?
- modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Mar 2015
- Phase
- Phase 3
- 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
- 18 years of age and stroke within 14 days
- Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
- Person that can understand instruction and do tests and questionnaires on their own or with support
- has given informed consent
- MFI-20 score of 12 or more
- Infertile person or fertile women tested negative of pregnancy and using safe anticonception
Who cannot join
- Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
- Other disease with fatigue as a known symptom
- stroke induced by trauma, infection or surgical procedure
- former drug abuse
- known contraindication to treatment with modafinil
- known active malignancy, benign intracranial tumor, subdural or epidural bleeding
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- kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
- allergy to project treatment
- use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
- Patients threaded with ciclosporin or anti HIV medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index
This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.
- Conditions
- Stroke, Post Stroke Fatigue
- Being tested
- modafinil, placebo
- Keywords
- stroke, fatigue, modafinil
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called modiodal, provigil
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
placeboDrug
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
| Modafinil | Active comparator | Modafinil Receives: Drug: modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Fatigue Inventory (MFI- 20)
Questionnaire
Measured: 3 months
Secondary outcomes (5)
MFI-20
Questionnaire
Measured: 1 month
MFI-20
Questionnaire
Measured: 6 months
Fatigue severity scale (FSS)
Measured: 3 months
FSS
Questionnaire
Measured: 1 month
FSS
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Overgaard, Herlev Hospital
- Investigators
- Karsten Overgaard, MD, Principal investigator, Department of Neurology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800097
- Sponsor's protocol ID
- ModaA001
- Status last verified
- Jun 2015
- First submitted
- 23 Oct 2012
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poulsen MB, Damgaard B, Zerahn B, Overgaard K, Rasmussen RS. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial. Stroke. 2015 Dec;46(12):3470-7. doi: 10.1161/STROKEAHA.115.010860. Epub 2015 Nov 3.
PubMed 26534969
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index
- ClinicalTrials.gov ID
- NCT01800097
- Acronym / sponsor ID
- ModaA001
- Conditions
- Stroke, Post Stroke Fatigue
- Keywords
- stroke, fatigue, modafinil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Feb 2013 (estimated)
- 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 is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.
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 |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo |
| Modafinil | Active comparator | Drug: modafinilModafinil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and stroke within 14 days
- Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
- Person that can understand instruction and do tests and questionnaires on their own or with support
- has given informed consent
- MFI-20 score of 12 or more
Key exclusion criteria (10 listed)
- Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
- Other disease with fatigue as a known symptom
- stroke induced by trauma, infection or surgical procedure
- former drug abuse
- known contraindication to treatment with modafinil
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 |
|---|---|---|
| modafinilAlso: modiodal, provigilTablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months | Drug | Modafinil |
| placeboTablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months. | Drug | placebo |
Primary outcome
Multidimensional Fatigue Inventory (MFI- 20)
Time frame: 3 months
Questionnaire
5 secondary outcomes
MFI-20
Time frame: 1 month
MFI-20
Time frame: 6 months
Fatigue severity scale (FSS)
Time frame: 3 months
FSS
Time frame: 1 month
FSS
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 26534969Poulsen MB, Damgaard B, Zerahn B, Overgaard K, Rasmussen RS. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial. Stroke. 2015 Dec;46(12):3470-7. doi: 10.1161/STROKEAHA.115.010860. Epub 2015 Nov 3.
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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.
Karsten Overgaard, MD principal investigator
Department of Neurology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing modafinil in people with Stroke and Post Stroke Fatigue, run by Herlev Hospital at 1 site in Denmark.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Multidimensional Fatigue Inventory (MFI- 20) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800097, which also lists 1 linked publication.
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 24 Jun 2015.