Bipolar DisorderPhase 1NCT00907985
A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
A Phase 1 study testing Vofopitant and Lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will 1. Assess the effects of drug A and drug B on muscle movement after brain stimulation; 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Vofopitant and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2009to 10 Jun 2010
- Phase
- Phase 1
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject
- Male aged 18-65
- Greater than 50kg weight
- BMI 19-29.9 kg/m2
Who cannot join
- Positive drug/alcohol screen
- Positive HIV antibody
- History of drug dependence
- History of neurological disease
- Pacemaker
- Smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will
- Assess the effects of drug A and drug B on muscle movement after brain stimulation;
- Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
- Examine the safety of drug A and drug B when given together.
- Conditions
- Bipolar Disorder
- Being tested
- Placebo, Vofopitant, Lamotrigine
- Keywords
- Healthy Volunteer, Resting motor threshold (rMT), Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose of placebo will be provided.
VofopitantDrug
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
LamotrigineDrug
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence A | Experimental | Subjects on sequence A will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence B | Experimental | Subjects on sequence B will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence C | Experimental | Subjects on sequence C will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence D | Experimental | Subjects on sequence D will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence E | Experimental | Subjects on sequence E will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence F | Experimental | Subjects on sequence F will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence G | Experimental | Subjects on sequence G will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence H | Experimental | Subjects on sequence H will receive single dose of placebo part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence I | Experimental | Subjects on sequence I will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence J | Experimental | Subjects on sequence J will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence K | Experimental | Subjects on sequence K will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence L | Experimental | Subjects on sequence L will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence M | Experimental | Subjects on sequence M will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence N | Experimental | Subjects on sequence N will receive single dose of vofopitant 10 milligrams capsule in part 1, placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence O | Experimental | Subjects on sequence O will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence P | Experimental | Subjects on sequence P will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence Q | Experimental | Subjects on sequence Q will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence R | Experimental | Subjects on sequence R will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence S | Experimental | Subjects on sequence S will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
| Treatment sequence T | Experimental | Subjects on sequence T will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2. Receives: Drug: Placebo; Drug: Vofopitant; Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the study treatments on Resting Motor Thresholds (rMT)
Measured: Within 24 hours
Secondary outcomes (1)
The safety and tolerability of the combination of study treatments.
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study start15 May 2009
- Primary completion10 Jun 2010
- Study completion10 Jun 2010
Why it stopped: Slow recruitment; trial unlikely to reach completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907985
- Sponsor's protocol ID
- 112676
- Status last verified
- Jul 2017
- First submitted
- 7 May 2009
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00907985
- Acronym / sponsor ID
- 112676
- Conditions
- Bipolar Disorder
- Keywords
- Healthy Volunteer, Resting motor threshold (rMT), Transcranial magnetic stimulation (TMS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment; trial unlikely to reach completion
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 May 2009 (actual)
- Primary completion
- 10 Jun 2010 (actual)
- Study completion
- 10 Jun 2010 (actual)
- First posted
- 25 May 2009 (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.
The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will
- Assess the effects of drug A and drug B on muscle movement after brain stimulation;
- Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
- Examine the safety of drug A and drug B when given together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence A | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence A will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence B | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence B will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence C | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence C will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence D | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence D will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence E | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence E will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence F | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence F will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence G | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence G will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence H | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence H will receive single dose of placebo part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence I | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence I will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence J | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence J will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. |
| Treatment sequence K | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence K will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2. |
| Treatment sequence L | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence L will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. |
| Treatment sequence M | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence M will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence N | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence N will receive single dose of vofopitant 10 milligrams capsule in part 1, placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. |
| Treatment sequence O | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence O will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence P | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence P will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2. |
| Treatment sequence Q | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence Q will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence R | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence R will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2. |
| Treatment sequence S | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence S will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2. |
| Treatment sequence T | Experimental | Drug: Placebo, Drug: Vofopitant, Drug: LamotrigineSubjects on sequence T will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subject
- Male aged 18-65
- Greater than 50kg weight
- BMI 19-29.9 kg/m2
Key exclusion criteria (6 listed)
- Positive drug/alcohol screen
- Positive HIV antibody
- History of drug dependence
- History of neurological disease
- Pacemaker
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 |
|---|---|---|
| PlaceboSingle dose of placebo will be provided. | Drug | Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D, Treatment sequence E, Treatment sequence F, Treatment sequence G, Treatment sequence H, Treatment sequence I, Treatment sequence J, Treatment sequence K, Treatment sequence L, Treatment sequence M, Treatment sequence N, Treatment sequence O, Treatment sequence P, Treatment sequence Q, Treatment sequence R, Treatment sequence S, Treatment sequence T |
| VofopitantVofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. | Drug | Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D, Treatment sequence E, Treatment sequence F, Treatment sequence G, Treatment sequence H, Treatment sequence I, Treatment sequence J, Treatment sequence K, Treatment sequence L, Treatment sequence M, Treatment sequence N, Treatment sequence O, Treatment sequence P, Treatment sequence Q, Treatment sequence R, Treatment sequence S, Treatment sequence T |
| LamotrigineLamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally. | Drug | Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D, Treatment sequence E, Treatment sequence F, Treatment sequence G, Treatment sequence H, Treatment sequence I, Treatment sequence J, Treatment sequence K, Treatment sequence L, Treatment sequence M, Treatment sequence N, Treatment sequence O, Treatment sequence P, Treatment sequence Q, Treatment sequence R, Treatment sequence S, Treatment sequence T |
Primary outcome
Effect of the study treatments on Resting Motor Thresholds (rMT)
Time frame: Within 24 hours
1 secondary outcome
The safety and tolerability of the combination of study treatments.
Time frame: Within 24 hours
Results and safety
The study was stopped early (reason given: Slow recruitment; trial unlikely to reach completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 112676 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vofopitant and Lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 1 site in Germany.
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 4 inclusion and 6 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 21 Jul 2017. 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 Germany. 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 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.
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; trial unlikely to reach completion). 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?
Effect of the study treatments on Resting Motor Thresholds (rMT) (time frame: Within 24 hours). 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 21 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.