Partial SeizuresPhase 4PREPS MEXICONCT00407797
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
A Phase 4 study testing Pregabalin in people with Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Mexico.
Trial summary
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Seizures
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 8 sitesMexico
- Study dates
- Mar 2007to Aug 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.
Who cannot join
- Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Mexico8 sites
Pfizer Investigational Site
Acapulco de Juárez, Guerrero, 39670
Pfizer Investigational Site
Aguascalientes, 20127
Pfizer Investigational Site
Chihuahua City, 31238
Pfizer Investigational Site
Estado de México, CP 52763
Pfizer Investigational Site
México, D. F., CP 06700
Pfizer Investigational Site
Monterrey, Nuevo León, 64060
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
Pfizer Investigational Site
Morelia, Michoacán, CP 58000
About this study
Official title: Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
Read the detailed description
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
- Conditions
- Partial Seizures
- Being tested
- Pregabalin
- Keywords
- Lyrica, Epilepsies - Partial
- Medical subject headings
- Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
150 to 600 mg/day during 21 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
Measured: Week 9 to Week 21 or End of Treatment (early termination)
Secondary outcomes (11)
Response Ratio (RR)
Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.
Measured: Week 9 to Week 21 or End of Treatment (early termination)
Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21
Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.
Measured: Week 21 or End of Treatment (early termination)
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.
Measured: Week 9 to Week 21 or End of Treatment (early termination)
Percent of Seizure- Free Participants During the Treatment Observation Period
Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).
Measured: Week 9 to Week 21 or Early Termination (end of treatment)
Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period
Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).
Measured: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Measured: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Measured: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.
Measured: Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.
Measured: Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.
Measured: Week 21, LOCF
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.
Measured: Week 21, LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionAug 2009
- Study completionAug 2009
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 Partial SeizuresStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407797
- Sponsor's protocol ID
- A0081090
- Acronym
- PREPS MEXICO
- Status last verified
- Feb 2011
- First submitted
- 1 Dec 2006
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
- ClinicalTrials.gov ID
- NCT00407797
- Acronym / sponsor ID
- PREPS MEXICO / A0081090
- Conditions
- Partial Seizures
- Keywords
- Lyrica, Epilepsies - Partial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Posted 9 Sep 2010
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 assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
Detailed description
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.
Key exclusion criteria (1 listed)
- Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
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 |
|---|---|---|
| Pregabalin150 to 600 mg/day during 21 weeks | Drug | Pregabalin |
Primary outcome
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
11 secondary outcomes
Response Ratio (RR)
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21
Time frame: Week 21 or End of Treatment (early termination)
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
Percent of Seizure- Free Participants During the Treatment Observation Period
Time frame: Week 9 to Week 21 or Early Termination (end of treatment)
Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period
Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Time frame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Time frame: Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Time frame: Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
Time frame: Week 21, LOCF
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 21, LOCF
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- 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.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Mexico.
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 1 inclusion and 1 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Sep 2010). 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?
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase (time frame: Week 9 to Week 21 or End of Treatment (early termination)). 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 25 Jan 2021.