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Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

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ClinicalTrials.gov Identifier: NCT03179345
Recruitment Status : Completed
First Posted : June 7, 2017
Results First Posted : May 13, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Depomed

Brief Summary:
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gabapentin Drug: Pregabalin Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Other
Official Title: A Phase 4, Double-Blind, Placebo-Controlled, Crossover Study Comparing Simulated Driving Performance, Daytime Sedation, and Cognition in Healthy Volunteers Taking Therapeutic Doses of Gralise®, Neurontin®, or Lyrica®
Actual Study Start Date : September 24, 2015
Actual Primary Completion Date : November 20, 2015
Actual Study Completion Date : November 20, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gralise® (gabapentin)
Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule.
Drug: Gabapentin
Other Name: Gralise®, Neurontin®

Active Comparator: Neurontin® (gabapentin)
Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.
Drug: Gabapentin
Other Name: Gralise®, Neurontin®

Active Comparator: Lyrica® (pregabalin)
Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.
Drug: Pregabalin
Other Name: Lyrica®

Placebo Comparator: Placebo (sugar pill)
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Other: Placebo
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® [ Time Frame: Baseline and Hour 3 on Day 3 ]
    SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.


Secondary Outcome Measures :
  1. Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® [ Time Frame: Baseline and Hour 3 on Day 3 ]
    SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.

  2. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance.

  3. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Cogstate - The Groton Maze Learning test is a measure Executive Function. Total number of errors made while attempting to learn the same hidden pathway across the consecutive learning trials performed at a single assessment. Lower score means better performance. Higher change from baseline means better performance.

  4. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Cogstate - Identification Task (IDN) assesses Attention. Score is speed of performance (mean of the log10 transformed reaction times for correct responses). Lower score (quicker speed) is better performance. Higher change from baseline means better performance.

  5. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Cogstate - International Shopping List (ISL) test is a measure of verbal learning and uses a well-validated list-learning paradigm. Total number of correct responses remembering the word list on three consecutive trials at a single assessment. Higher score is better performance. Higher change from baseline means better performance.

  6. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Cogstate - The One Card Learning Test (OCLT) is a measure of visual learning and uses a well-validated pattern separation paradigm with playing card stimuli. Higher Score is better performance. Higher change from baseline means better performance.

  7. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep

  8. Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Portland Neurotoxicity Scale (PNS) comprises 15 questions measured on a 10-point scale. [1=No problem, 2, 3, 4, 5=Often a problem, 6, 7, 8, 9, 10=Severe problem] in 16 categories. Each question was analyzed and is presented in the same way as the primary endpoints.

  9. Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Miles per Hour (mph)

  10. Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). [ Time Frame: Baseline and Hour 3 on Day 3 ]
    Miles per Hour (mph)

  11. To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. [ Time Frame: Screening to 1 week after Period 4 discharge ]
    • Number of subjects with Treatment-Emergent Adverse Events (TEAE)
    • Number of subjects with Serious Adverse Event (SAE)
    • Number of subjects discontinued due to Adverse Event (AE)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 40 and 80 years of age, inclusive.
  • Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.
  • Able to give informed consent.
  • Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
  • Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
  • Karolinska Sleep Scale (KSS) score of <=5.
  • Other criteria apply.

Exclusion Criteria:

  • Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
  • Pregnant or lactating or considered at risk of pregnancy.
  • Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
  • Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
  • Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
  • History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
  • Other criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179345


Sponsors and Collaborators
Depomed
Investigators
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Study Director: Head of R&D Depomed
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT03179345    
Other Study ID Numbers: GRAL-PX-8401
First Posted: June 7, 2017    Key Record Dates
Results First Posted: May 13, 2020
Last Update Posted: June 1, 2020
Last Verified: April 2020
Keywords provided by Depomed:
Volunteer
Pharmacodynamics
Pharmacokinetics
Additional relevant MeSH terms:
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Pregabalin
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents